MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number VTICM5_13.2

Device Problems Cut In Material (2454); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the u.S.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter stated that the surgeon noticed a tear on a 13.2mm vticm5_13.2 implantable collamer lens,-8.5/+3.0/94 (sphere/cylinder/axis), when the lens was removed from the vial.The lens was not used, no patient contact.

Manufacturer Narrative

Additional data: device evaluation: the lens was returned in a liquid inside a lens case/ vial.Visual inspection found the haptic torn and the lens missing a piece of its haptic.There was presence of fiber- like debris on the lens surface.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7206051
• MDR Text Key: 97898468
• Report Number: 2023826-2018-00102
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR